FDA applicant

Scanlan Intl., Inc.

Mchenry, IL19 decisions1978–19960 recalls

FDA records 19 decisions for Scanlan Intl., Inc. (Mchenry, IL) from 1978 to 1996: 19 510(k) clearances. Most are in product codes HRQ (Hemostat) and DWS (Instruments, Surgical, Cardiovascular). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Scanlan Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scanlan Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scanlan Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Scanlan Intl., Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?